The Liver BIoBank Lombardia of Fatty Liver

NCT06566105 | Recruiting

• 1 other identifier: LIVER BIBLE
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

NAFLD is most frequently linked to excess adiposity, insulin resistance and cardiometabolic risk factors, it has become the leading cause of liver disease worldwide, and is associated with increased mortality due to multiple causes. HFC has a strong genetic component and the investigators recently showed that it plays a causal role in determining progressive liver disease and insulin resistance. The genetic risk score predicting liver fat content (HFC-GRS) improves the stratification of liver related events, and the investigators have preliminary data on new common and rare variants that contribute to NAFLD susceptibility, and on a new non-invasive circulating biomarker associated with hepatic fat and lipotoxicity (Interleukin-32). However, no data are yet available on the causal role of hepatic fat on the procoagulant state associated with NAFLD, which could participate to liver damage and is a causal factor in atherothrombotic complications. The aim of the study is to examine the potential application of a precision medicine approach to the improvement of stratification of the risk of liver-related and cardiovascular thrombotic complications of hepatic fat accumulation (HFC) and non-alcoholic fatty liver disease (NAFLD), with a special focus on the role of procoagulant imbalance in mediating the at-risk phenotypes.

Conditions

NAFLD; Precision Medicine; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• association of liver fat accumulation

  At the time of enrollment, to test the association of liver fat accumulation (HFC) with liver disease and cardiovascular complications the association between HFC-genetic risk score (GRS) data will be collected on the characterization of clinical risk factors through Fibroscan measurement of liver stiffness, liver stiffness measurement (LSM) and controlled attenuation parameter (CAP), in subjects at higher metabolic risk and therefore dysteatosis. This information will be collected in the blood donor subject's management system.

  up to 48 months

• the role of liver fat

  The genetic risk score predicts liver fat content (HFC-GRS) can improve risk stratification of liver disease progression in NAFLD and how new common and rare genetic variants contribute to susceptibility to NAFLD. The same data also highlighted a possible new non-invasive circulating biomarker associated with liver fat and lipotoxicity (interleukin-32). So the evaluation of complete genetic risk scores (GRS) can be used to stratify the risk of liver-related complications and to select the best pharmacological therapy. Technological advances that enable the interrogation of the entire human genome, combined with the exploitation of bioinformatics systems approaches, are proving promising for providing patients and clinicians with unique health information from the molecular, cellular to multi-organ levels. By taking advantage of these new technologies, we assessed the role of liver fat (HFC) in coagulation alterations and influence cardiovascular risk.

  up to 48 months

Study Arms (1)

PROCEDURES RELATED TO THE STUDY

OTHER

* Selection of blood donors at risk of NAFLD and metabolic diseases and sample collection blood * Evaluation of early cardiovascular damage and characterization of liver damage in patients with high probability of severe NAFLD * Study of genomics and biomarkers * Generation of an in vitro genetic model of NAFLD

Genetic: precision medicine approach

Interventions

precision medicine approach GENETIC

precision medicine approach to improvement of risk stratification of hepatic and cardiovascular complications in non-alcoholic fatty liver disease in a group of healthy subjects at increased risk of metabolic pathologies

PROCEDURES RELATED TO THE STUDY

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Blood donors aged between 40 and 65 years presence of clinical diagnosis of overweight or obesity (body mass index-BMI \> 25 kg/m2),
• increased fasting blood glucose or T2D (fasting blood glucose ≥100mg/dl) or dyslipidemia (triglycerides≥150mg/dl, HDL\<45/55 in M/F) or arterial hypertension (n = 2,452, 11.8% of the entire cohort).

You may not qualify if:

• subjects suffering from chronic degenerative diseases, except hypertension in good compensation and diabetes type 2 mellitus which does not require pharmacological therapy (as is already common practice for eligibility for donation of blood)
• donors aged \> 65 and \< 40 to avoid the introduction of bias

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Luca Vittorio Carlo Valenti

CONTACT

02 5503 6595; luca.valenti@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: August 22, 2024
• Study Start: June 1, 2020
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2037
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IT (1)